ADS051 / Adiso Therap - LARVOL DELTA

Adiso Therapeutics Announces Data Publication of Two Phase 1 Studies of First-in-Class Neutrophil Modulator ADS051 in the American Journal of Gastroenterology (PRNewswire) - "The first of the two publications presents the results from the single ascending dose (SAD) trial of ADS051...There were no dose-limiting toxicities, serious adverse events (AEs), or trial discontinuation due to AEs. Pharmacokinetic data demonstrated minimal systemic absorption of ADS051, with the majority of drug excreted in the stool as expected. There was no clinical evidence of adverse immunosuppressive activity...The second publication presents the results of a multiple ascending dose (MAD) study of ADS051 in patients with moderately to severely active UC...The study also looked at neutrophil-related markers of inflammation and histologic assessment. As detailed in the publication, this study achieved its primary endpoint of safety and tolerability with encouraging signs of efficacy across multiple outcome measures."

P1 data • Ulcerative Colitis

SAFETY, PHARMACOKINETICS, AND CLINICAL EFFICACY OF ADS051, A NEUTROPHIL MODULATOR, IN ULCERATIVE COLITIS: RESULTS OF A RANDOMIZED PHASE 1B TRIAL. (PubMed, Am J Gastroenterol) - "Phase 1b data in patients with UC indicate a favorable safety profile for ADS051 with encouraging signals of clinical activity, supporting the advancement to a Phase 2 trial."

Journal • P1 data • PK/PD data • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

Small-Molecule Neutrophil Modulator ADS051 Is Safe and Well-Tolerated in a Phase 1 Single Ascending Dose Study. (PubMed, Am J Gastroenterol) - "ADS051 was safe, well tolerated, and achieved high stool concentrations with minimal systemic exposure. ADS051 could be a safe and effective, locally acting, neutrophil-targeting agent for the treatment of UC."

Journal • P1 data • Constipation • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Mucositis • Ulcerative Colitis

Geneoscopy and Adiso Therapeutics Announce Strategic Collaboration to Investigate New Therapeutic Options for Patients with Inflammatory Bowel Disease (Businesswire) - "Geneoscopy, Inc...and Adiso Therapeutics, Inc...announced a strategic collaboration to further treatment options available for patients with inflammatory bowel disease (IBD). The agreement allows Geneoscopy’s patented RNA biomarker technology to be used in conjunction with ADS051, a first-in-class, oral, gut-restricted, small molecule modulator of neutrophil trafficking and activation being developed by Adiso for the treatment of IBD....The Adiso ADS051 Phase 2 clinical study will be conducted globally and begin recruiting in 2024."

Licensing / partnership • New P2 trial • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

ADS051, an Oral, Gut-Restricted, Small Molecule Neutrophil Modulator in Patients With Moderate-To-Severe Ulcerative Colitis: Results From a Multiple Ascending Dose Study (ACG 2023) - P1 | "ADS051 is a novel, oral, gut-restricted small molecule derived from a cyclosporine A scaffold. All 24 patients enrolled completed the study (8/cohort); 16.7% of patients on ADS051 vs 66.7% on placebo had at least 1 treatment-emergent adverse event (TEAE). No serious adverse events were reported. No TEAE resulted in dose modification or drug discontinuation."

Clinical • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Adiso Therapeutics Announces Positive Topline Data from Phase 1b Study of ADS051 for the Treatment of Moderate-to-Severe Ulcerative Colitis (PRNewswire) - P1b | N=24 | SCOUT (NCT05084261) | Sponsor: Adiso Therapeutics | "Adiso Therapeutics... announced positive topline data from its Phase 1b multiple ascending dose (MAD) clinical trial evaluating ADS051 (BT051) in patients with moderate-to-severe ulcerative colitis (UC). The data were presented today at the American College of Gastroenterology (ACG) 2023 Annual Scientific Meeting being held October 20-25, in Vancouver, Canada....On Day 28, for pooled ADS051 participants vs. pooled placebo participants, clinical remission was achieved in 22.2% vs. 0%, endoscopic improvement (investigator blinded, centrally-read) in 33.3% vs 0%, and endoscopic response (centrally-read) (UCEIS) was achieved in 50% vs. 17%....'We plan to advance ADS051 in a Phase 2 clinical study in early 2024'."

New P2 trial • P1 data • Ulcerative Colitis

Development of ADS051, an oral, gut-restricted, small molecule neutrophil modulator for the treatment of neutrophil-mediated inflammatory diseases. (PubMed, FEBS Open Bio) - "ADS051, based on a modified scaffold derived from cyclosporine A (CsA), was designed to have reduced affinity for calcineurin with low cell permeability and, thus, a greatly reduced ability to inhibit T-cell function. In addition, preclinical toxicology studies in rats and monkeys receiving daily oral doses of ADS051 for 28 days did not reveal safety risks or ADS051-related toxicity. Our results to date support the clinical development of ADS051 in patients with neutrophil-mediated inflammatory diseases."

Journal • Inflammation

Adiso Therapeutics Announces the Completion of a Phase 1b Multiple Ascending Dose Study of ADS051 for the Treatment of Moderately-to-Severely Active Ulcerative Colitis (PRNewswire) - "Adiso Therapeutics, Inc...announced the completion of a Phase 1b multiple ascending dose (MAD) clinical trial evaluating ADS051 (BT051) an oral, gut-restricted, small molecule modulator of neutrophil trafficking and activation. The randomized double-blind placebo-controlled study enrolled 24 moderately-to-severely active ulcerative colitis (UC) patients, all of whom completed the trial as planned over the 28-day treatment period. ADS051 was found to be safe and well-tolerated with each daily oral dose in all 3 dosing cohorts (200mg, 800mg and 3200mg)....The combined Phase 1a/1b data packages have enabled Adiso to submit an End of Phase 1 meeting request to the Food and Drug Administration, as the Company intends to pursue a Phase 2 development program in late 2023."

New P2 trial • Trial completion • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

SCOUT: An Investigation of Oral BT051 in Subjects With Moderately to Severely Active Ulcerative Colitis (UC) (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: Adiso Therapeutics | Recruiting ➔ Completed | N=44 ➔ 24 | Trial completion date: Aug 2023 ➔ Nov 2022 | Trial primary completion date: Aug 2023 ➔ Nov 2022

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Colon Cancer • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Solid Tumor • Ulcerative Colitis

Adiso Therapeutics Provides Development Update Reflecting Strong Progress Across Its Pipeline (PRNewswire) - “Adiso Therapeutics, Inc…announced that enrollment in the third cohort of its Phase 1b study of ADS051 for the treatment of moderate-to-severe ulcerative colitis is complete….‘We are very pleased to confirm all patients have been enrolled into the ascending dose cohorts, with the third cohort enrollment of our Phase 1b study of ADS051 for ulcerative colitis, an important milestone for Adiso…’”

Enrollment status • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Adiso Therapeutics (BIO 2022) - "Adiso has three distinct candidates that may change the treatment paradigm for inflammatory diseases: ADS051, an oral gut-restricted modulator of neutrophil trafficking and activation; ADS024, an oral single strain live biotherapeutic product (SSLBP); and ADS032 a dual NLRP1/NLRP3 inflammasome inhibitor. Adiso has built these programs upon a rich history of institutional and academic collaboration, including the University College Cork, Ireland, the APC Microbiome Institute, the University of Massachusetts Chan Medical School, the Hudson Institute of Medical Sciences Centre for Innate Immunity and Infectious Diseases in Australia and the University of Edinburgh Centre for Inflammation Research. Adiso was founded in 2022 and is based in Concord, MA,"

Immunology • Infectious Disease • Inflammation • NLRP1 • NLRP3

Adiso Therapeutics to Present at BioNJ's 12th Annual BioPartnering Conference (PRNewswire) - "Adiso Therapeutics, Inc...will present virtually at BioNJ's 12th Annual BioPartnering Conference....Mr. Megaffin will present the Adiso pipeline of products...The Adiso pipeline includes two small molecules with novel mechanisms of action and single strain live biotherapeutic products (SS-LBP), rapidly advancing in clinical-stage development programs for ulcerative colitis and c. difficile."

Clinical • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Adiso Therapeutics Announces Completion of First Cohort Enrollment in a Phase 1b Study of ADS051 for the Treatment of Moderately-to-Severely Active Ulcerative Colitis (PRNewswire) - P1b | N=44 | SCOUT (NCT05084261) | Sponsor: Adiso Therapeutics | "Adiso Therapeutics, Inc...announced that it has completed enrollment of its first cohort of patients in a Phase 1b clinical study evaluating ADS051 (BT051), an oral, gut-restricted, small molecule modulator of neutrophil trafficking and activation, as a potential treatment for patients with moderately-to-severely active ulcerative colitis (UC). Blinded data indicated that dosing in this cohort was safe and well-tolerated, supporting initiation of enrollment of the second higher dose cohort."

Enrollment status • P1 data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Morningside Ventures Launches Adiso Therapeutics to Advance Novel Therapies for Inflammatory Diseases (PRNewswire) - "Morningside Ventures today announced the launch of Adiso Therapeutics, a clinical-stage biotechnology company advancing a pipeline of novel therapeutics targeting inflammatory diseases. Morningside has financed the Adiso development plans to date, with plans to further support the company's rapid growth moving forward. Adiso is advancing an innovative pipeline of small molecules with novel mechanisms of action and single strain live biotherapeutic products (SS-LBP), pursuing lead indications in ulcerative colitis (UC), and C. difficile infection (CDI)."

Financing • Inflammatory Bowel Disease • Ulcerative Colitis

SCOUT: An Investigation of Oral BT051 in Subjects With Moderately to Severely Active Ulcerative Colitis (UC) (clinicaltrials.gov) - P1; N=44; Recruiting; Sponsor: Bacainn Therapeutics, Inc.; Trial primary completion date: May 2023 ➔ Aug 2023

Clinical • Trial primary completion date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

A Phase 1, Single-Ascending-Dose Study of BT051 in Healthy Subjects (clinicaltrials.gov) - P1; N=50; Completed; Sponsor: Bacainn Therapeutics, Inc.

Clinical • New P1 trial

SCOUT: An Investigation of Oral BT051 in Subjects With Moderately to Severely Active Ulcerative Colitis (UC) (clinicaltrials.gov) - P1; N=44; Recruiting; Sponsor: Bacainn Therapeutics, Inc.

Clinical • New P1 trial • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Bacainn Therapeutics Presents at ECCO ‘21 Results from Phase 1 Study that Shows BT051, an Oral, Locally-Acting Inhibitor of Neutrophil Trafficking and Activity, Is Safe and Well-Tolerated in Healthy Adults (Businesswire) - P1, N=NA; "Bacainn Therapeutics, Inc...presented results at the European Crohn’s and Colitis Organisation’s 2021 Virtual Congress from a Phase 1 study that showed its lead asset BT051 was safe and well-tolerated in healthy adults."

P1 data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

[VIRTUAL] Safety, tolerability and pharmacokinetics of BT051, an oral inhibitor of neutrophil migration and activation in clinical development for Inflammatory Bowel Disease (ECCO-IBD 2021) - "Conclusion Single ascending doses up to 3500 mg of BT051 were safe and well-tolerated in healthy subjects. Stool concentrations out to 7 days postdose that exceed the expected efficacious threshold, minimal to no systemic exposure and the lack of systemic immunosuppression support the continued development of BT051 as a gut-targeted therapy for patients with IBD."

Clinical • PK/PD data • Immunology • Inflammation • Inflammatory Bowel Disease

Bacainn Therapeutics Reports Positive Topline Results from Phase 1 Study of BT051, a Novel Therapeutic Approach to Treat Inflammatory Diseases Such As Ulcerative Colitis (Businesswire) - P1, N=50; "Bacainn Therapeutics, Inc...today announced the successful completion of the company’s Phase 1, first-in-human clinical trial of BT051, a novel, orally administered, gut-selective inhibitor of migration and activation of neutrophils...Single doses of BT051 up to 3500 mg were generally safe and well tolerated in all healthy subjects exposed...Bacainn Therapeutics plans to initiate a Phase 1b clinical trial of BT051 in patients with moderate to severe active ulcerative colitis in 2021. Full results from the completed phase 1 clinical trial will be shared at a future scientific congress."

New P1 trial • P1 data • Inflammatory Bowel Disease • Ulcerative Colitis